Community 2.0 – Webinar Q&A
- Will there also be automatic messages about new CT version - plus updated availability of the latest CT in the Validator tool?
Yes, OpenCDISC Community will notify users about availability of new versions of CDISC Control Terminology. Auto-Update functionality will upload new versions into the tool. - Is there a help text or menu inside the application?
You can find a link to OpenCDISC documentation under Help menu. - Could you indicate when you could look at the CT version and MedDRA versions used in the define.xml file included?
The first page of validation report has a list of dictionary versions used. It includes CDISC CT and MedDRA. All validation parameters should be provided by the user in GUI. In previous versions of Validator, define.xml metadata was used to populate MedDRA version. However now the industry compliance with define.xml standard is not high enough to consider define.xml as a reliable source of MedDRA version. Therefore we changed validation configuration logic to utilize parameter entered directly into the system by a user. - Did you show how to access/generate the metadata?
Yes, use Define.xml Generator tool in OpenCDISC Community 2.0 to scan and retrieve metadata from datasets. You can also view our Creating Define.xml 2.0 with OpenCDISC webinar. - Do you have access to the database behind clinicaltrials.gov?
No, the current version of Miner utilizes only the publicly available API on clinicaltrials.gov website. - Can OpenCDISC 2.0 validate the define.xml files against the define 1.0 standard?
Yes, Validator works with both define.xml versions 1.0 and 2.0. Define.xml Generator tool can also read both versions 1.0 and 2.0, but it will only generate Define.xml 2.0. - Can one access the OpenCDISC Community 2.0 functionality via command line (e.g. DOS) or can the functionality only be accessed from within the application's GUI?
Yes, OpenCDISC Community 2.0 supports Command Line Interface (CLI) for Validator and Data Converter tools. Please see our website for documentation. - Do you know if the FDA plans to have Automatic Updates enabled, or will they control their installed versions of this suite of tools and enforce these with Sponsors' submissions?
FDA is using DataFit which is FDA's implementation of OpenCDISC Enterprise with independent release schedule. FDA specific validation configurations are released in OpenCDISC Community only after they have already been vetted by FDA CCB and were deployed and tested in DataFit. - After installation of the software to the hard disk of the computer the program can be started, but as soon as the Browse button is used in the CDISC validator module to select SAS XPORT files the program is being shut down immediately. Are there any prerequisites for installation of the software?
No, there are no prerequisites for software installation. You only need to select the applicable package (Mac OS X, Win 64-bit, Win 32-bit), download and unzip it. OpenCDISC Community 2.0 package includes Java and other dependencies. You can also install and run OpenCDISC Community from external USB drive using the same packages. - Concerning dictionary / terminology - what about WHO-DD for medications? - is there a way to switch off for example checks against MedDRA coding in case the MedDRA version used by the study is not available /installed in the validator we have installed in our pc/server?
WHO Drug dictionary is not included in OpenCDISC Community 2.0, but it will be implemented soon. MedDRA files can be installed by following instruction on OpenCDISC.org - Is the data converter only available in the OpenCDISC enterprise version? Once the define-xml files are created from first pointing to the define.xml, do the links from define.xml access the define-xml files?
Data Converter is a part of OpenCDISC Community. Define.xml links to datasets point to the same folder as a location of define.xml file. Links to documents (annotated CRFs, Reviewer Guide, Study Protocol, etc.) are defined by Href attribute. See CDISC Define.XML v2.0 documentation for details. - Does the MedDRA and CT come with the OCV? Or does the user need to configure the location of MedDRA and CT in his local desk environment?
5 most recent versions of CDISC Control Terminology (CT) are included in OpenCDISC Community 2.0. Auto-Update procedure will add any new CT versions as they become available. MedDRA dictionary is not included due to MedDRA licensing limitations. Users must use their own MedDRA files. See OpenCDISC.org for documentation. - When is this presentation to be available on YouTube? Is the previous webinar, introducing the FDA Validation checks, available now?
Yes, all our webinars are available on YouTube in 2 weeks after events. Announcement about their availability is usually present in OpenCDISC Community tool, OpenCDISC.org website, Pinnacle 21 Blog and subscription emails. - What is the url of the source code repository?
OpenCDISC source code repository is available at https://bitbucket.org/opencdisc. A link to source code repository is also available on the tools download page at http://www.opencdisc.org/download. - Are all validation ID from FDA included in this?
Yes, all FDA published rules are implemented in OpenCDISC Community 2.0 - How to validate the Define.xml file in OpenCDISC Validator
Open the OpenCDISC Validator tool, choose Standard as "Define.xml" and select the applicable version. - When you create the define.xml (excel spreadsheets) from the data, can you also populate the ValueLevel metadata using the xxTESTCD/xxTEST from the data?
No, the current version of Define.xml tool does not populate Value Level metadata from xpt files. This functionality is available only in Enterprise edition. - Will the ADaM define.xml generator be able to report split level domains or results-level metadata?
Define.xml tool supports split datasets and Value Level metadata. Analysis results metadata is not a part of current versions of Define.xml standard and is not supported by OpenCDISC Community 2.0. - Is the batch functionality working as before?
Command Line Interface (CLI) is available for Validator and Data Converter tools. Please see OpenCDISC.org website for documentation. - There is no option for selecting SDTM terminology versions when we are validating Define.xml
An option to select a version of CDISC Terminology for define.xml validation will be introduced later. - What are the limitation with respect to enterprise edition with regards to define.xml generation? So provided we correctly fill the xls template, will we always get a proper define.xml 2.0 with all elements with the standard version?
OpenCDISC Community Define.xml tool includes basic, but complete functionality to create study metadata in standardized format by using Microsoft Excel. OpenCDISC Enterprise edition, on the other hand, may be considered as a basic metadata repository. It's a web-based application designed for corporate clients. Some examples of additional functionality are usage of custom standards, extracting Value Level metadata, scanning annotated CRFs, importing external specs, generating define.pdf, live validation for metadata integrity, version control, metadata comparison, quick reference to all repository metadata, etc. - Are rules planned from Japan (JMH) or Europe (EMEA)?
The rules from other international Regulatory Agencies will be available after their official publication. - Can the define.xml tool to be used on ADaM dataset?
Yes, Define.xml tool can be used for ADaM data in addition to SDTM and SEND. - Where are the preferences saved in windows? registry?
OpenCDISC Community does not make any changes to user's operational system or registry. OpenCDISC Community can run independently on Windows, Mac and even from USB drive. - Hey Max, does OC validate "Dataset XML" files?
Yes, OpenCDISC Community 2.0 Validator supports Dataset-XML format.
